Interax Knee Midi 1 Tibial Inserts. Interax Tib Ins Midi 1 10mm Lft.
FDA device recall Z-0853-03 · posted 2003-05-21 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics
- Reason for recall
- The device is demonstrating early wear and delamination.
- Action taken
- Recall letters were sent to the Howmedica branches and hospitals on January 23, 2003 via FedEx.
- Root cause
- Other
- Status
- Terminated
- Product code
- JWH
- Quantity affected
- 1
- Distribution
- Howmedica distributed this device to 2 Howmedica branches and 3 hospitals are Parkview Episcopal Hospital, Pueblo, CO; St. Mary Corwin Hospital, Pueblo, CO; and Hement Valley Hospital, Riverside, CA.
- Date initiated
- 2003-01-23
- Date posted
- 2003-05-21
- Date terminated
- 2004-12-01
- Location
- Mahwah, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INTERAX TOTAL KNEE SYSTEM (K973121) | Howmedica Corp. | 1997-11-18 |